Tumor ImmunityPhase 2NCT04150744
RFA Plus Carrizumab vs Carrizumab Alone for HCC
A Phase 2 study testing radiofrequency ablation in people with Tumor Immunity and Immunosuppression, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The study aims to find whether patients with advanced HCC can get more benefits from RFA +PD-1 immunosuppressant (carrizumab) compared with carrizumab alone, considering with the result of PFS. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Tumor Immunity, Immunosuppression, Radiofrequency Ablation
- What is being tested?
- radiofrequency ablation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 30 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age from 18-75 years
- Diagnosis as hepatocellular carcinoma from histology and cytology
- BCLC B-C degree
- Score of ECOG PS: 0-2
- Child-Pugh Score: A or B
- Not suitable for resection or liver transplantation
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- Have not received systemic therapy
- Have at least one evaluable target mass from CT or MRI according to mRECIST
- The estimated survival time ≥ 12 weeks
- Patients with HBV infection having HBV-DNA <500IU/mL and standard anti-virus treatment. Patients with HCV infection must receive standard anti-virus treatment.
- The function of main organs normal
- Sign informed consent
Who cannot join
- Have cholangiocarcinoma, mixed type of hepatocarcinoma and fibrolamellar hepatocellular carcinoma. Have incurable malignant tumor in five years.
- Have local ablation, TACE or radiotherapy in 3 months before enrolled.
- Prepared to or have received organic or bone marrow transplantation.
- Uncontrollable ascites, hepatic encephalopathy or esophageal and gastric varices.
- Have hypertension and can't lower down to the normal level using blood pressure medication.
- Have type II myocardial ischemia or myocardial infarction, uncontrollable arrhythmia.
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- Have diseases to influent the effect of oral drugs, for example, unable to swallow, chronic diarrhea and intestinal obstruction.
- Have gastrointestinal bleeding in 6 months
- Have abdominal fistula, gastrointestinal perforation or abdominal abscess
- Patients with lung fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug related pneumonia or severe dysfunction of lung.
- Routine urine test showed urinary protein ≥++ or the 24 hours amount of urinary protein ≥1.0 g
- Patients have autoimmune disease
- Patients need corticosteroid or other immunosuppressant therapy
- Patients have anti-tumor vaccine and other immunostimulate anti-tumor drugs in 3 months
- Allergy to monocloning antibody
- Pregnant or breastfeeding female Other patients not suitable to be enrolled in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
Zhe Tang, Dr., 13757118212, 8xi@zju.edu.cn
About this study
Official title: Radiofrequency Ablation Plus Carrizumab vs Carrizumab Alone for Moderate or Advanced Hepatocellular Carcinoma: A Real World Study
The study aims to find whether patients with advanced HCC can get more benefits from RFA +PD-1 immunosuppressant (carrizumab) compared with carrizumab alone, considering with the result of PFS.
Read the detailed description
The study aims to find whether patients with advanced HCC can get more benefits from RFA +PD-1 immunosuppressant (carrizumab) compared with carrizumab alone, considering with the result of PFS. 120 patients were enrolled into two groups respectively, the experimental group and reference group.
- Conditions
- Tumor Immunity, Immunosuppression, Radiofrequency Ablation
- Being tested
- radiofrequency ablation
- Keywords
- RFA, immunosuppressant, hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency ablationCombination product
take advantage of RFA to destroy hepatocellular carcinoma by high temperature
| Study group | Role | What they receive |
|---|---|---|
| RFA plus carrizumab | Experimental | Not described Receives: Combination Product: radiofrequency ablation |
| carrizumab | Placebo comparator | Not described Receives: Combination Product: radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Time from patients received treatment fist time to disease progress or death
Measured: through study completion, an average of 4 years
Secondary outcomes (4)
Objective response rate
The ratio of patients with regressive disease ,including complete response and partial response
Measured: through study completion, an average of 4 years
Disease control rate
The ratio of patients with regressive or stable disease, including complete response, partial response and stable disease.
Measured: through study completion, an average of 4 years
Overall survival
Time from the random assignment to death (the last follow-up time for patients lost to follow-up, the end of study for patients still alive
Measured: through study completion, an average of 4 years
Duration of response
Time from the first time of complete regression or partial regression to progressive disease or death
Measured: through study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start1 Aug 2020 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor ImmunityStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhe Tang, Dr., Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150744
- Sponsor's protocol ID
- 1102320191018
- Status last verified
- Oct 2019
- First submitted
- 28 Oct 2019
- Last updated
- 8 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation Plus Carrizumab vs Carrizumab Alone for Moderate or Advanced Hepatocellular Carcinoma: A Real World Study
- ClinicalTrials.gov ID
- NCT04150744
- Acronym / sponsor ID
- 1102320191018
- Conditions
- Tumor Immunity, Immunosuppression, Radiofrequency Ablation
- Keywords
- RFA, immunosuppressant, hepatocellular carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to find whether patients with advanced HCC can get more benefits from RFA +PD-1 immunosuppressant (carrizumab) compared with carrizumab alone, considering with the result of PFS.
Detailed description
The study aims to find whether patients with advanced HCC can get more benefits from RFA +PD-1 immunosuppressant (carrizumab) compared with carrizumab alone, considering with the result of PFS. 120 patients were enrolled into two groups respectively, the experimental group and reference group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RFA plus carrizumab | Experimental | Combination Product: radiofrequency ablation |
| carrizumab | Placebo comparator | Combination Product: radiofrequency ablation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age from 18-75 years
- Diagnosis as hepatocellular carcinoma from histology and cytology
- BCLC B-C degree
- Score of ECOG PS: 0-2
- Child-Pugh Score: A or B
Key exclusion criteria (16 listed)
- Have cholangiocarcinoma, mixed type of hepatocarcinoma and fibrolamellar hepatocellular carcinoma. Have incurable malignant tumor in five years.
- Have local ablation, TACE or radiotherapy in 3 months before enrolled.
- Prepared to or have received organic or bone marrow transplantation.
- Uncontrollable ascites, hepatic encephalopathy or esophageal and gastric varices.
- Have hypertension and can't lower down to the normal level using blood pressure medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiofrequency ablationtake advantage of RFA to destroy hepatocellular carcinoma by high temperature | Combination product | RFA plus carrizumab, carrizumab |
Primary outcome
Progression-free survival
Time frame: through study completion, an average of 4 years
Time from patients received treatment fist time to disease progress or death
4 secondary outcomes
Objective response rate
Time frame: through study completion, an average of 4 years
Disease control rate
Time frame: through study completion, an average of 4 years
Overall survival
Time frame: through study completion, an average of 4 years
Duration of response
Time frame: through study completion, an average of 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhe Tang, Dr. principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing radiofrequency ablation in people with Tumor Immunity and Immunosuppression, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhe Tang, Dr. (13757118212, 8xi@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: through study completion, an average of 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.